NCT00859014已完成1 期
Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Study Related Serious Adverse Events (SR-SAE)
研究概览
简要总结
The purpose of this research study is to find out if bone marrow treatment (bone marrow aspiration and infusion of stem cells) can be safely used in adults who have recently (within 24-72 hours)suffered an acute ischemic stroke.
详细描述
Our primary hypothesis is that autologous bone marrow mononuclear cell transplantation by intravenous administration is feasible and safe after acute ischemic stroke. Our secondary hypothesis is that autologous transplantation is associated with improved outcome after acute stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic stroke
- •age 18 to 83 years If >80 then the pre-stroke mRS needs to be < 1)
- •Right hemisphere NIHSS 6 -15, left hemisphere NIHSS 6-18
- •known onset time of acute symptoms
- •stem cell transplantation procedure must be performed within 24 to 72 hrs after stroke symptom onset
- •TPA infusion is allowed
排除标准
- •NIHSS 1a > 1
- •pre-stroke mRS > 1 if > 80 years of age
- •Ischemic stroke in the last 3 months, any vascular territory
- •MI, primary hemorrhagic or traumatic lesion of the brain within the last 3 months or identified on MRI. Small hemorrhagic transformation of the acute infarct is allowed.
- •seizure disorder
- •developmental delay
- •chronic kidney disease defined as baseline creatinine >1.4
- •hepatic disease or altered liver function as defined by SGPT >150 U/L and or T. Bilirubin >1.6 mg/dL at admission
- •pulmonary disease (e.g, COPD with oxygen-requirement at rest or with ambulation, moderate to severe asthma)
- •mechanical heart valve
- •Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening or any history of chemotherapy or radiation affecting the bone marrow. Skin cancers (except for melanoma) are permitted.
- •prior immunosuppression, including chemotherapy administration within last 3 years or current immunosuppression as defined by WBC <3 x 103 cells/ml
- •hemoglobin <10g/dl
- •uncorrected coagulopathy at the time of consent defined as INR >1.4; PTT>37 sec, or thrombocytopenia (PLT<100,000)
- •any hemodynamic instability at the time of consent (e.g, requiring continuous fluid resuscitation or ionotropic support).
- •Hypoxemia (SaO2<90%) at the time of consent, respiratory distress or persistent hypoxemia defined as SaO2 <94% for >30 minutes occurring at any time from hospital admission to time of consent. Intubation alone is not an exclusion.
- •pregnancy or positive b-HCG
- •current participation in any interventional research study
- •unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
- •Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)
- •Unable to undergo MRI or CT scan
- •Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
- •Exclude infarct lesion size >145cc unless the NIHSS 1a remains < 1 and there is no evidence of infarct expansion or edema formation on any imaging obtained from admission up to the point just prior to infusion.
- •Exclude IA therapy use or if there is a planned or anticipated hemicraniectomy. Diagnostic angiograms are allowed
- •CT and/or Multimodal MRI exclusion criteria will be:
- •hemispheric strokes < 1.5 cm maximum diameter (on the MRI as seen on the diffusion-weighted imaging or CT)
- •midline shift >1mm or significant hemorrhagic transformation of the acute infarct
结局指标
主要结局
Study Related Serious Adverse Events (SR-SAE)
时间窗: 2 Years
Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"
次要结局
- Functional Outcome(90-days)
研究者
Sean Savitz
Professor, Neurology
The University of Texas Health Science Center, Houston
研究点 (2)
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